Clinical Trials in the USA / NCT05607810
Active, not recruiting
Observational
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
NCT05607810 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Diabetic Macular EdemaDiabetic Retinopathy
Investigational drug(s) / intervention(s)
ADVM-022
ADVM-022: Long term follow-up of subjects who previously received ADVM-022 (Ixo-vec)
Study summary
This is a prospective, observational study designed to evaluate the long-term safety and tolerability of ADVM-022 in participants with diabetic macular edema (DME). Participants who previously participated in the INFINITY parent study and received a single unilateral intravitreal dose of ADVM-022 are eligible for enrollment upon completion of the end of study visit in the parent study.
Eligibility
Inclusion Criteria:
* Must have participated in the ADVM-022-04 \[INFINITY\] (parent) study and received ADVM-022
* Must provide signed informed consent
* Must be willing and able to comply with all study procedures
Exclusion Criteria:
\- None
Primary outcome measure(s)
- Incidence of ocular and non-ocular adverse events (AEs) — 168 Weeks
- Severity of ocular and non-ocular AEs — 168 Weeks
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Adverum Clinical Site | Beverly Hills | California | |
| Adverum Clinical Site | Reno | Nevada | |
| Adverum Clinical Site | Philadelphia | Pennsylvania | |
| Adverum Clinical Site | Austin | Texas | |
| Adverum Clinical Site | Bellaire | Texas | |
| Adverum Clinical Site | The Woodlands | Texas | |
| Adverum Clinical Site | Arecibo | Puerto Rico |
More Adverum Biotechnologies, Inc. trials in the USA
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Active, not recruiting
Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration
Active, not recruiting
Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]
Active, not recruiting
Other trials for the same condition
EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05607810 on ClinicalTrials.gov ↗ ← All trials in the USA